A high-loading, fast-dissolving ferric citrate composition and its preparation method

A technology of ferric citrate and high drug loading, applied in drug combination, drug delivery, pharmaceutical formulation, etc., to achieve the effect of product quality satisfaction

Active Publication Date: 2017-07-14
CHENGDU XINJIE HIGH TECH DEV CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] From the analysis of the above patents, it can be seen that in order to meet the requirements of the relevant indicators of the coated tablet for the tablet under the high drug loading, it also needs to meet the requirements of rapid dissolution in vitro and meet the requirements of its immediate release preparation, but these patents Published formulations and manufacturing processes have their own limitations

Method used

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  • A high-loading, fast-dissolving ferric citrate composition and its preparation method
  • A high-loading, fast-dissolving ferric citrate composition and its preparation method
  • A high-loading, fast-dissolving ferric citrate composition and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] formula1234 Iron citrate hydrate 1200mg 1200mg 1200mg 1200mg Powdered cellulose 100mg 110mg 120mg 130mg corn starch 30mg 10mg 20mg 10mg Gelatin-xanthan gum mixture 5mg 5mg 5mg 5mg Pure water Right amount Right amount Right amount Right amount Calcium stearate 30mg 30mg 30mg 30mg Premixed coating powder Right amount Right amount Right amount Right amount

[0036] .

[0037] Weigh the materials according to formula 1, crush them mechanically, pass through a 100-mesh sieve, and prepare them for use; prepare the gelatin-xanthan gum mixture with purified water; combine the mechanically crushed iron citrate hydrate and powdered cellulose in multiple Mix in a sports mixer for 20 minutes, collect the materials, and set aside.

[0038] Put the mixed materials in a high-efficiency wet granulator, shear at high speed for 60 seconds, stop high-speed shear, turn on low-speed shear, add gelatin-xanthan gum mixture aqueous solution for granulation, and adjust the binder according...

Embodiment 2-4

[0043] Weigh the materials according to formula 2-4, and the preparation method is the same as in Example 1.

Embodiment 5

[0044] Example 5 In vitro dissolution measurement method

[0045] Dissolution method: slurry method, 100 revolutions / min; solvent: pH 1.2 solution (sodium chloride 2.0g, concentrated hydrochloric acid 7ml, add water to 1000ml) 1000ml; time: 15min, Q value ≥90%.

[0046] Concentration of reference solution: 0.45mg / ml.

[0047] Drug concentration detection method: UV method; 220nm.

[0048] Evaluation method of other indicators: ChP2010. Two Appendix IB.

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Abstract

The invention discloses a ferric citrate composition high in drug loading capacity and capable of being dissolved out quickly. The ferric citrate composition comprises, by weight, 1200-1500 parts of ferric citrate aquo-complex, 110-160 parts of filling agents, 90-150 parts of disintegrating agents, 5-10 parts of binding agents, 10-20 parts of pure water and 10-30 parts of lubricating agents. The invention further discloses a preparation method of the ferric citrate composition. The ferric citrate composition can guarantee smooth industrial production of ferric citrate tablets at high drug loading capacity, meanwhile, the quality of products can meet the requirements of in vitro quick dissolving out and satisfy demands of fast-release preparations.

Description

Technical field [0001] The invention relates to an iron citrate composition with high drug loading and rapid dissolution and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Hyperphosphatemia is a common complication of chronic kidney disease (CKD), especially end stage renal disease (ESRD) patients, and can be seen in 80% of dialysis patients. Hyperphosphatemia stimulates the parathyroid glands to secrete a large amount of parathyroid hormone, which is an important factor in causing secondary hyperparathyroidism, changes in calcium and phosphorus deposition, vitamin D metabolism disorders, and renal bone disease. Hyperphosphatemia is also closely related to coronary artery disease, heart valve calcification and other serious cardiovascular complications. Adjusting reasonable phosphorus metabolism is the key to reducing cardiovascular complications, improving the quality of life of dialysis patients, and reducing d...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/30A61K31/194A61P3/00A61P13/12
Inventor 蒲洪陈小宁许娟
Owner CHENGDU XINJIE HIGH TECH DEV CO LTD
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